The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions

Abstract

Objectives: This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo ® Temporary Pacing Lead.Background: Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability.Methods: Data from 269 consecutive structural heart procedures were collected.Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed.Results: The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA.There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment.

Innovative use of biotrace tempo pacemaker lead following cardiac surgery

“…The Tempo Temporary Pacing Lead has been used in structural heart and electrophysiology procedures for temporary pacemaking since regulatory approval in 2016. [ 1 ] The lead is a temporary, transvenous, active-fixation pacemaker. The Tempo lead may have distinct advantages compared to epicardial leads traditionally used in the perioperative period for cardiac surgery, and this report is the first documented use of this device following cardiac surgery.…”

Rapid pacing using device programmers: A complex procedural simplification?

“…Although that is an easy procedure all operators are familiar with, a few serious complications can occur: right ventricular perforation and cardiac tamponade, intermittent capture with risk of valve embolization/malpositioning, pro‐arrhythmic effect and vascular complications. In an attempt to reduce these complications, different devices and techniques have been explored, including: use of lower‐profile and softer leads, balloon‐tipped catheters, active fixation leads, 2 and LV pacing through the wire used for valve deployment 3 …”

“…Left ventricular pacing via the valve delivery guidewire is being adopted with growing confidence by operators, and was associated with significantly reduced procedure duration, fluoroscopy time, and cost in a randomized trial, with similar efficacy and safety 3 . The Tempo temporary pacing lead (BioTrace Medical, Inc., Menlo Park, CA) has a soft tip and a novel active fixation mechanism designed to enhance lead stability, and preliminary results are promising, although it adds cost to the procedure and a few cases of loss of capture have been reported 2 …”